Kornimate/medical-research-clean huggingface dataset:
shared decision making: prostate cancer screening

Conditions: Prostate Cancer

Summary: interventions to improve shared decision-making: prostate cancer screening is a prospective study of educational interventions to improve the interaction of physicians and their patients about prostate cancer screening. educational material is provided in primary care practices using either standard paper information or a novel web-based interactive curriculum that explores the risks and benefits of screening measures for prostate cancer for older men. the impact of the intervention on shared decision-making with both actual and standardized patients will be assessed.

prostate cancer is an important cause of death and disability in us men, but the value of screening for the disease with the prostate specific antigen (psa) test remains highly controversial. many primary care physicians use psa testing routinely, with little patient counseling. interventions to improve shared decision-making: prostate cancer screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. in addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. the intervention will be evaluated among 140 physicians within a variety of primary care settings (i.e., university-based clinics, staff-model managed care clinics, and military affiliated outpatient clinics). approximately 10-15 actual patients of each participating physician will complete a post-visit questionnaire describing their discussion with their doctor about prostate cancer, psa, and their decision about whether to be screened. physicians in all groups will also see one unannounced standardized patient (sp) trained to portray a patient interested in discussing psa. study groups will be compared on the extent of shared decision-making they engage in with both actual and standardized patients. pre- and post-study changes in physician knowledge and attitudes about psa as well as the physicians' pre- and post-study psa test ordering rates will be ascertained.

Eligibility criteria:
inclusion criteria: * physicians in primary care practice settings with male patients age 50-75 exclusion criteria: * none

Keywords: shared decision-making prostate cancer screening evidence-based medicine computer-assisted learning tools standardized patients randomized controlled trial educational intervention patient education physician education
convivo system to discriminate healthy tissues vs tumor tissues during brain tumor resection

Conditions: Brain Tumor

Summary: the purpose of the study is to do a direct comparison of the convivo system (camera imaging device) with our normal stanford pathology process. convivo system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

primary objective: the primary objective of this study is to determine the feasibility of using the convivo imaging system to identify tumor type. secondary objective: the secondary objectives are to determine the average time needed for tissue visualization with the convivo system as compared to standard cryosectioning, and to describe the ability of the convivo imaging -to describe the ability of the convivo imaging system to generate readable images.

Eligibility criteria:
inclusion criteria: * the subject demonstrates the ability to understand and the willingness to sign a written informed consent document. * the subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma. * the subject has been deemed eligible for surgical resection by a practicing stanford physician. * macroscopic tumor visualization using iv infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment. * the subject is older than 18 years. * the subject is receiving their surgery at stanford hospital. exclusion criteria: \* patients with any kind of contraindication to the use of fluorescein
a clinical study to evaluate the safety, tolerability, pharmacokinetics and biologic effect of vg2025 in patients with solid tumors

Conditions: Advanced Malignant Solid Tumor

Summary: vg2025 is a recombinant human il12/15 dual-regulated oncolytic hsv-1 injection. this phase i study will be conducted in herpes simplex virus (hsv) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. this is an open label study to determine the safety and tolerability of vg2025, and recommended dose of vg2025 for phase ii trials.

this is a phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. the trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the maximum tolerated dose (mtd) and the recommended phase 2 dose (rp2d). dose limiting toxicity (dlt) evaluation period is for 4 weeks from the start of treatment day 1 through day 28.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent form. 2. age 18 to 75 years (inclusive), male or female. 3. subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage. 4. eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment. exclusion criteria: 1. subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug. 2. subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug. 3. in the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on. 4. other active uncontrolled infection. 5. known alcohol or drug dependence. 6. subjects with mental disorders or poor compliance. 7. women who are pregnant or breastfeeding. 8. subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
bioequivalence between an oral nicotine replacement product and nicorette® gum

Conditions: Tobacco Dependence

Summary: this study examines the bioequivalence between an oral nicotine replacement product and nicorette® gum.

the study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). the investigational products will be given as single doses at separate treatment visits. periods without nicotine replacement therapy (nrt), lasting for at least 36 hours, will separate treatment visits. blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. used gums will be collected and analyzed to determine the amount of remaining nicotine. subjects will also be monitored to capture any adverse events that may occur.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (bmi) between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation nicotine pharmacokinetics
dosing study of ranibizumab for diabetic retinal and macular edema

Conditions: Diabetic Retinopathy; Macular Edema

Summary: this study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

this is a prospective randomized study comparing two groups of patients with diabetic macular edema. one group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. that is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * patient related considerations * phakic or pseudophakic patients with a known history of diabetes will be eligible. * women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug. * disease related considerations: * patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication. * patients will have a bcva etdrs snellen-equivalent less than or equal to 20/40 * central foveal thickness on sd-oct of \>300um exclusion criteria: * pregnancy (positive pregnancy test) or lactation premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch. * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial * foveal ischemia on ivfa * intraocular surgery less than 6 months ago * epiretinal membrane of clinical significance * prior vitrectomy * uncontrolled glaucoma * macular or peripheral laser within 90 days from day 0 injection * intravitreal steroid injection within 90 days from day 0 injection * intravitreal or systemic anti-vegf within 30 days from day 0 injection

Keywords: diabetic macular edema diabetic retinal swelling diabetic eye disease
efficacy and safety of ato plus atra in nucleophosmin-1 mutated acute myeloid leukemia

Conditions: AML

Summary: in this open-label, randomized, prospective clinical trial, nucleophosmin-1(npm1) mutated acute myeloid leukemia (aml) patients who have reached cr are randomized into two groups.the control group receive high-dose cytarabine(hdac) regimen while the experimental group receive high dose of cytarabine plus tretinoin(atra) and arsenic trioxide(ato) treatment.the safety and efficacy of atra and ato is evaluated.

in this open-label, randomized, prospective clinical trial, npm1- mutated aml patients who have reached cr are randomized into two groups. in experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day, atra at a dose of 30mg/㎡/d on day 1-14 and ato at a dose of 0.15mg/kg/d (maximum, 10mg/d) on day 1-14. patients in control group only receive high dose of cytarabine. the safety and efficacy of atra plus ato regimen is evaluated.the primary outcome is relapse-free survival rate after treatment.

Eligibility criteria:
inclusion criteria: 1. age of 14 to 55 years old; 2. patients that meet the diagnostic criteria(who 2008 criteria) of aml (except apl subtypes) and with npm1-mutated. 3. reached cr after induction regimen. 4. ecog score of ≤ 2; 5. patients with eligible laboratory examination including liver,renal and heart function. 6. adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. patients under 18 years old willing to participate should have their legal guardians sign the informed consent. exclusion criteria: 1. secondary leukemia. 2. patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 3. patients with other blood diseases(for example, haemophiliacs) are excluded.however, patients with abnormal blood count, but with undiagnosed mds or mpd patients are included. 4. acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 5. with bcr-abl fusion gene; 6. pregnant or lactating women; 7. with ineligible renal or liver function; 8. with active cardiovascular disease; 9. severe infection disease including uncured tuberculosis pulmonary aspergillosis; 10. aids; 11. patients had central nervous system involvement when they were diagnosed as aml. 12. patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. 13. drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. 14. patients with other factors which were considered unsuitable to participate in the study by the investigators.
nutritional supplements & complementary/alternative medicine by prostate & breast cancer patients

Conditions: Prostate Cancer; Breast Cancer

Summary: this study was a survey to determine the frequency of complementary and alternative medicine (cam) use in patients recently diagnosed with breast or prostate cancer who were starting radiation therapy. the survey was repeated at three time points to assess changes in cam use over time.


Eligibility criteria:
inclusion/exclusions * men that have histologically proven carcinoma of the prostate and have chosen some form of radiation therapy as their primary therapy for prostate cancer. * women who are undergoing external beam radiation therapy to the breast as primary or adjuvant therapy are eligible. * all participants must be able to read and write. * subjects with dementia and mental retardation that complicates completing the questionnaires will not be enrolled. * subjects with known metastatic disease will be excluded. * there are no age restrictions for this study.

Keywords: cam alternative medicine
the influences of dry eye disease on optical quality

Conditions: Dry Eye; Vision; Disturbance, Hysterical

Summary: ded could result in visual disturbance and damage optical quality. we aimed to evaluate the influences of dry eye disease (ded) on optical quality and their correlations.

this study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.

Eligibility criteria:
inclusion criteria: 1. patients were diagnosed as dry eye according to the criteria provided by the dry eye workshop (dews) 2. positive corneal fluorescein staining (cfs) 3. best-corrected distance visual acuity better than 20/20. exclusion criteria: history of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.
treating tuberculosis wasting with a high-protein supplement

Conditions: Tuberculosis; Tuberculosis, Pulmonary; Undernutrition; Malnutrition

Summary: undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an increased relapse risk. the purpose of this study is to test the effect of lacprodan® di-8090 whey protein concentrate on anthropometric measures, treatment outcome and health-related quality of life, against standard practice during anti-tuberculous treatment on patients with a bmi \<20 living in guinea-bissau.

it is hypothesized that patients with tuberculosis receiving whey protein concentrate as nutritional supplement will experience a greater gain in adverse anthropometric measures, and experience a decreased risk of relapse and death, compared with patients with tuberculosis, who do not receive nutritional supplement. 260 patients will be recruited from and included/randomized at 4 trial sites in bissau, guinea-bissau (bandim health center, belem health center, cuntum health center and hospital raoul follereau). patients randomized to the intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day for the duration of the 6-month long anti-tuberculous treatment. patients will be followed bimonthly during the treatment period, with clinical examinations, blood sample analyses, and nutritional status and dietary intake assessments.

Eligibility criteria:
inclusion criteria: * patients diagnosed with tb * aged 18 years and above * bmi\<20 exclusion criteria: * pregnancy * commencement of treatment ≥30 days prior to inclusion * decreased kidney function * missing informed consent * mentally ill/disabled patients unable to comply with the treatment/intervention regimen

Keywords: nutritional supplement health-related quality of life dietary intake
unilateral laparoscopic diathermy adjusted to ovarian volume

Conditions: PCOS

Summary: the objective of our study was to compare the efficiency of the right ulod using thermal doses adjusted to ovarian volume (60 j/cm3) with the blod method at constant dose and to assess treatment efficiency.

the study included 96 infertile, clomiphene citrate-resistant women with polycystic ovary syndrome (pcos), who underwent either unilateral or bilateral laparoscopic diathermy at the clinical hospital split, croatia. pcos was diagnosed following the rotterdam consensus criteria. in the ulod group, we treated the right ovary with thermal dose of 60 j applied per one cubic centimeter of ovarian. in the comparator, blod group, all patients received 600 j per ovary. the follow-up period encompassed six menstrual cycles for all subjects.sample size was based on the test of the primary hypothesis that ulod treatment would result in a higher ovulation rate than blod. in our pilot study in 61 patients, ovulation rates were estimated to 44% in the blod arm and 69% in the ulod arm. assuming 5% significance and 80% power, we calculated that the minimal sample size for a one-sided test had to be 96 patients. the aims of our prospective study: 1. compare the efficiency of the right ulod using thermal doses adjusted to ovarian volume (60 j/cm3) with the blod method at constant dose and to assess treatment efficiency and predict ovulatory response based on clinical parameters (right or left ovary and its volume) and received thermal doses. 2. evidence the effects of ulod using thermal doses adjusted to ovarian volume on endocrine (changes in androgen and amh) and reproductive outcomes (ovulation rate) in clomiphene-resistant women with pcos. 3. to determine whether unilateral laparoscopic ovarian drilling (ulod) using thermal doses adjusted to ovarian volume diminishes ovarian reserve less than bilateral lod (blod) using a fixed thermal dose

Eligibility criteria:
pcos was diagnosed following the rotterdam consensus criteria inclusion criteria: * age between 25 and 35 years, * bmi\<30 kg/m2, * infertility period 1-3 years, * normal partner's semen findings, * lh≥10 or lh:fsh ratio ≥2, * testosterone \>2.5 nmol/l, * fai\>4, * normal oral glucose tolerance test (ogtt). exclusion criteria: * adrenal hyperplasia, * thyroid disease, * cushing's syndrome, * hyperprolactinemia, * tumor-related androgen excess

Keywords: polycystic ovary syndrome,laparoscopic ovarian drilling
use of real-time functional magnetic resonance imaging neurofeedback to improve motor function in cerebellar ataxia

Conditions: Healthy

Summary: this project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fmri nf) in conjunction with motor imagery. to do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.


Eligibility criteria:
inclusion criteria: * 18-100 years of age * at least 8th-grade education * right-handedness exclusion criteria: * history of axis i psychiatric disorders (including alcohol and drug dependence) * severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy * history of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae * any condition that is contraindicated for the mri environment (e.g., metal in the body, pacemaker, claustrophobia) * currently pregnant * eligible subjects may be asked to refrain from medications that affect the central nervous system that would also make data difficult to interpret (e.g., sedatives) for an appropriate period of time prior to scanning * participants will be excluded if they do not have a home computer with internet available to complete the 3-week at-home component of the study protocol

Keywords: cerebellar ataxia healthy controls ataxia spinocerebellar ataxias cerebellar diseases neurodegenerative diseases movement disorders cerebellum gait balance
allogeneic umbilical cord mesenchymal stem cell therapy for autism

Conditions: Autism

Summary: allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (iv) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect in autism patients.


Eligibility criteria:
inclusion criteria: * male or female * ages 6 to 16 * diagnostic and statistical manual of mental disorders (dsm iv) diagnosis of autism confirmed by autism diagnostic observation schedule (ados) and/or autism diagnostic interview-revised (adi-r) * no anticipated changes in treatment for the study duration (e.g., diet, nutrients) * no additional biomedical treatments started 6 weeks prior to enrollment * no changes in dietary management for 3 months prior to enrollment * ambulatory or require minimum support walking, per parent * able to sit still for 5 minutes or longer with a preferred toy item, per parent * adequate vision and hearing for the purposes of test administration, per parent * adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent * stable and controlled mental disorder * under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures * normal heavy metals test for lead and mercury levels performed within 30 days of first stem cell infusion * must provide name and specialty of specialist who has made autism spectrum disorder (asd) diagnosis * adequate financial means to cover $7,200 (us dollars) plus travel expenses exclusion criteria: * significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (sga - small for gestational age) * mental retardation * seizure disorder * auto-immune conditions * history of head trauma and other neurological or medical conditions * abnormal heavy metals test for lead and mercury performed within 30 days of first stem cell infusion * prior stem cell therapy of any kind

Keywords: autism umbilical cord mesenchymal stem cells